# K013930: Neurosensor

- Pathway: 510(k) (Traditional)
- Applicant: Novus Monitoring, Ltd.
- Decided: Feb 20, 2002 after 84 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875179 (1988). 7 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914479: Microsensor Intracranial Pressure Transducer, Codman & Shurtleff, Inc. (1994) Summary page 1.
- K896515: Laserflo Blood Perfusion Monitor, Model BPM2, Tsi, Inc. (1990) Summary page 1.
- K961368: Trimflo Parenchymal Blood Flow Monitoring Probe Kit, Vasamedics, LLC (1996) Summary page 2.
- K974088: Codman Intracranial Bolt, Johnson & Johnson Professionals, Inc. (1998) Summary page 2.

## Most influential descendants
- K050702: Neurosystems 1TM Monitor (2005), 17 descendants of its own
- K061640: Integra Mobius Multi-Modality Monitoring System (2006), 15 descendants of its own
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own

## Indications for use
The NeuroSensor™ System is intended for use by a qualified neurosurgeon in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.

Source page: https://510kreport.com/device/K013930
Methodology: https://510kreport.com/methodology